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Effect of Cimetidine on the PK of Imeglimin

NCT03618316 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2018-08-27

No results posted yet for this study

Summary

The trial is an open-label assessment of the interaction of imeglimin with cimetidine. Up to 16 healthy men and women will receive a single oral dose of 1,500 mg imeglimin alone followed by a second dose of imeglimin during repeated doses of 400 mg cimetidine taken twice daily for 6 days.

Conditions

  • Healthy

Interventions

DRUG

Imeglimin

2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)

DRUG

Cimetidine

400 mg of cimetidine bid from Day 5 to Day 10

Sponsors & Collaborators

  • Poxel SA

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-19
Primary Completion
2018-07-21
Completion
2018-07-27

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03618316 on ClinicalTrials.gov